Are older people disadvantaged by new guidelines?

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Close to one-third of patients eligible for lipid-lowering therapy were not taking a statin, and around one in five were receiving potentially unnecessary repeat LDL testing in a study designed to examine the impact of the new guidelines on current cardiovascular clinical practice.

Note that another study found that many patients meeting the new blood pressure target goal of <150/90 mm Hg (for patients ages 60 and older without diabetes or chronic kidney disease) are still at high cardiovascular risk and might benefit from treatment to the lower target of <140/90.

Close to one-third of patients eligible for lipid-lowering therapy, as defined by the 2013 American College of Cardiology/American Heart Association cholesterol guidelines, were not taking a statin, and around one in five were receiving potentially unnecessary repeat LDL testing in a study designed to examine the impact of the new guidelines on current cardiovascular clinical practice.

The study is one of two appearing in the latest issue of the Journal of the American College of Cardiology, published online Nov. 19, examining the clinical impact of controversial new treatment guidelines for the prevention of heart attack and stroke.

A second study by the same research group examined the impact of 2014 hypertension treatment recommendations from panel members appointed to the Eight Joint National Committee (disavowed by the National Heart, Lung and Blood Institute but unofficially known as JNC8). Those guidelines, among other things, raised blood pressure target goals from <140/90 mm Hg to <150/90 mm Hg for patients age 60 and older without diabetes or chronic kidney disease.

The study found that many patients meeting the new target but not the old are still at high cardiovascular risk and might benefit from treatment to the lower target, according to an accompanying editorial.

New Guidelines Abandoned Target Cholesterol Goal

In the cholesterol study, Thomas Maddox, MD, of the VA Eastern Colorado Health Care System, Denver, and colleagues, examined the impact of the new cholesterol guidelines, which abandoned the previous "treat to LDL cholesterol target" strategy in favor of a "treat to risk" approach.

Instead of recommending an LDL goal of less than 100 mg/dL, with an optimal goal of less than 70 mg/dL, for all patients with cardiovascular disease, the new guidelines identified high-risk groups to target with fixed-dose statin treatment. The abandonment of the target-LDL strategy also rendered repeat on-treatment testing unnecessary, Maddox and colleagues wrote.

"Because cardiologists typically treat patients at the highest risk for cardiac events, optimizing cholesterol management in light of these new guidelines would be expected to have significant impact," the researchers wrote. "Although there has been work published on the population impact of these new guidelines, important questions remain unanswered. In particular, little is known about current lipid-lowering therapies and LDL-C testing patterns, which would help quantify expected shifts in care and subsequent implications for statin use, nonstatin use, and LDL-C testing among risk groups."

Using data collected between 2008 and 2012 from the National Cardiovascular Data Registry (NCDR) Practice Innovation and Clinical Excellence (PINNACLE) Registry, which collects continuous, real-time clinical information on all patients treated in participating outpatient cardiology practices in the U.S., the researchers sought to determine the presence in the PINNACLE cohort of patients meeting eligibility criteria for statin therapy under the new guidelines and assess their current therapy and LDL-C testing patterns.

Among the no risk criteria group, 21,224 (47.5%) eligible patients were not receiving any lipid-lowering therapy, 1,929 (4.3%) were receiving nonstatin therapies, 15,201 (34.2%) were receiving statin therapies, and 6,356 (14.4%) were receiving both statin and nonstatin therapies.

During the study period, around half of patients (50.6%) had no LDL testing and 28.5% had one assessment. About one-fifth (20.8%) had two or more LDL-C assessments, and 7.0% had more than four assessments.

The researchers noted that the findings have several implications for cardiac patients, as the provider and patient community move toward adopting the 2013 guidelines.

"If the 377,311 eligible patients in the PINNACLE population not currently receiving statin therapy receive them as a result of these guideline changes, then those patients would have a 25% reduction, on average, in cardiovascular events," the researchers wrote, adding that the benefit would be especially pronounced among those with diabetes or an estimated ASCVD risk ≥7.5%, who were noted to have the highest rates of nonstatin use (36.2% and 36.6%, respectively) in this population.

'Older Adults Disadvantaged by New Guidelines'

In an editorial published with the study, Nanette Wenger, MD, of the Emory Heart and Vascular Center, Atlanta, wrote that the 2013 guidelines "selectively disadvantage" older adults who were largely absent from the randomized, controlled trials that informed them.

"The contemporary statin treatment-risk paradox is striking: despite the high attributable risk of hypercholesterolemia at elderly age, and the statin-associated reduction in all-cause mortality in this population, statin use declines sharply at elderly age."

She noted that for the functional elderly adult with few comorbidities, but the highest ASCVD event risk, continuing or initiating high-intensity statins "appears prudent."

"On the contrary, any statin as the 11th or 12th medication for a frail elderly adult with multiple comorbidities and polypharmacy risks appears of limited benefit."

New Hypertension Treatment Guidelines 'Major Shift'

The treatment of elderly patients was also a focus of a second analysis of PINNACLE registry data by Maddox and colleagues. In this study the researchers examined the clinical impact of the latest NHLBI Joint National Committee (JNC) on Detection, Evaluation, and Treatment of High Blood Pressure report (the 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults), from panel members appointed to the Eight Joint National Committee (commonly, but not officially, known as JNC 8).

Published earlier this year, the report "represents a major shift in the treatment of hypertension, and concern has been expressed about the public health impact of these less aggressive recommendations on efforts to prevent cardiovascular disease," the researchers wrote.

The most controversial aspect of those guidelines was the decision to raise blood pressure target goals from <140/90 mm Hg to <150/90 mm Hg for patients ages 60 and older without diabetes or chronic kidney disease. Five members of the JNC writing panel were so against the change that they published a separate report dissenting from the recommendation.

"With the substantial improvements in cardiovascular disease morbidity and mortality in the U.S. over the past few decades, yet knowing that only 50% of patients with hypertension currently receive treatment, critics -- including some members of the panel writing group itself -- argue that the 2014 panel recommendations could slow, halt, or even reverse these gains, especially among at-risk patient groups, such as elderly women and African Americans," Maddox and colleagues wrote.

Using the PINNACLE registry data the researchers assess the proportion of patients who met the 2003 ("JNC 7") and 2014 panel recommendations, highlighting the population of patients for whom the blood pressure goals had changed.

Using the 2014 recommendations, 880,378 (74.3%) patients were at goal.

Among the 173,519 (14.6%) for whom goal achievement changed, 40,323 (23.2%) had a prior stroke or transient ischemic attack, and 112,174 (64.6%) had coronary artery disease. In addition, the average Framingham risk score in this group was 8.5% (SD 3.2%), and the 10-year ASCVD risk score was 28.0% (SD 19.5%).

"Among U.S. ambulatory cardiology patients with hypertension, nearly one in seven who did not meet JNC 7 recommendations would now meet the 2014 treatment goals," the researchers wrote. "If the new recommendations are implemented in clinical practice, blood pressure target achievement and cardiovascular events will need careful monitoring, since many patients for whom the target blood pressure is now more permissive are at high cardiovascular risk."

The researchers estimated that treatment to a blood pressure target of <140/90 mm Hg instead of <150/90 mm Hg could potentially prevent 8,000 cardiovascular events over 10 years in the age 60 and older study population.

In an accompanying editorial, Clive Rosendorff, MD, PhD, of Mount Sinai Heart in New York City, wrote that the JNC 8 recommendation raising blood pressure targets to <150/90 mmHg in relatively healthy people in their 60s and older "contradicts the avalanche of (contemporary) hypertension guidelines," including those from the ACC, the AHA, the CDC, and the European Society of Cardiology.

Rosendorff cited an analysis, published in JAMA last spring, suggesting that 13.5 million patients with hypertension who were eligible for treatment under the old guidelines would not be treated under the new guidelines.

"This is the unintended consequence of what is otherwise a thoughtful and useful set of recommendations from some members of the JNC 8 Writing Committee for the management of hypertension," he wrote. "We do not know how practice patterns will change based on the JNC 8 panel recommendations, but it will be important to monitor these patterns, to follow blood pressure control on a population basis, especially in those patients older than 60 years and those with diabetes, and to follow any consequent changes in cardiovascular morbidity and mortality in these very large and growing segments of the population."

The research was supported by the American College of Cardiology.

The researchers disclosed no relevant relationships with industry.

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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